Olmesartans

These products have the same...
  • Active ingredients
  • Dosage strengths
  • FDA standards of quality and performance
... as their brand equivalents

Learn more about Teva Generic medicines

How to get this Teva Generic

Read more

INDICATIONS AND USAGE

Olmesartan Medoxomil Tablets and Olmesartan Medoxomil and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which these drugs principally belong. There are no controlled trials demonstrating risk reduction with either Olmesartan Medoxomil Tablets or Olmesartan Medoxomil and Hydrochlorothiazide Tablets.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

Olmesartan Medoxomil Tablets or Olmesartan Medoxomil and Hydrochlorothiazide Tablets may be used alone, or in combination with other antihypertensive drugs.

Olmesartan Medoxomil and Hydrochlorothiazide Tablets are not indicated for the initial therapy of hypertension.

Close
Read more

IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Olmesartan Medoxomil Tablets or Olmesartan Medoxomil and Hydrochlorothiazide Tablets as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Contraindications: Olmesartan Medoxomil Tablets or Olmesartan Medoxomil and Hydrochlorothiazide Tablets are contraindicated for coadministration with aliskiren in patients with diabetes. Olmesartan Medoxomil and Hydrochlorothiazide Tablets are contraindicated in patients with hypersensitivity to any component of the product and in patients with anuria.

Morbidity in Infants: Children < 1 year of age must not receive Olmesartan Medoxomil Tablets for hypertension. Drugs that act directly on the renin-angiotensin aldosterone system (RAAS) can have effects on the development of immature kidneys. Safety and effectiveness of Olmesartan Medoxomil and Hydrochlorothiazide Tablets have not been established in pediatric patients of any age.

Hypotension in Volume or Salt-Depleted Patients: In patients with an activated renin-angiotensin system, such as volume-or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with Olmesartan Medoxomil Tablets or Olmesartan Medoxomil and Hydrochlorothiazide Tablets. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.

Impaired Renal Function: Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on Olmesartan Medoxomil Tablets or Olmesartan Medoxomil and Hydrochlorothiazide Tablets. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function while taking Olmesartan Medoxomil Tablets or Olmesartan Medoxomil and Hydrochlorothiazide Tablets.

Hypersensitivity Reactions: Hypersensitivity reactions to Hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

Electrolyte and Metabolic Imbalances: Olmesartan Medoxomil and Hydrochlorothiazide Tablets contain Hydrochlorothiazide which can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels.

Olmesartan Medoxomil Tablets and Olmesartan Medoxomil and Hydrochlorothiazide Tablets contain olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically.

Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue Hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Systemic Lupus Erythematosus: Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Sprue-Like Enteropathy: Severe, chronic diarrhea with substantial weight loss has been reported in patients taking Olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with Olmesartan, exclude other etiologies. Consider discontinuation of treatment in cases where no other etiology is identified.

Common Adverse Reactions: The most common adverse reaction in clinical trials of Olmesartan Medoxomil Tablets in adults was dizziness (3%). The most common adverse reactions in clinical trials of Olmesartan Medoxomil and Hydrochlorothiazide Tablets in adults (incidence ≥ 2%) were nausea, hyperuricemia, dizziness, and upper respiratory infection.

Please see accompanying full Prescribing information, including Boxed Warning, for Olmesartan Medoxomil Tablets or Olmesartan Medoxomil and Hydrochlorothiazide Tablets.

TG-41204 April 2017

Close
Benicar® & Benicar HCT® are registered trademarks of Daiichi Sankyo Company.

Teva Product Catalog

The product catalog provides you with a full listing of Teva's brand and generic product lines.  The catalog displays all strengths and sizes along with the description, imprint code, NDC and photo for each product.

Get Informed

Sign up to receive email communication from Teva when new cost-saving Teva generics become available and other health information.

We will not share your email or personal information. View our Privacy Policy.